Find out more about the PACT-G study
Consent and baseline assessments
Participation in the study is entirely voluntary.
These assessments act as a start or ‘baseline’ against which we can measure any change in your child’s skills over the time you are involved in the study. During the sessions, the researcher will make a detailed assessment of your child’s social and communication abilities, their level of language, and their general level of learning ability.
Through questionnaires and interviews with you, we will gather detailed information about your child’s development and current skills at home, your experiences as parents and as a family, your understanding of your child’s skills and difficulties and what effect these may have had on your lives. We will make a short video of you and your child playing together to look at the way that you and your child communicate and interact together. Finally, we will want to find out about any help or services that you may have received over the previous six months and any additional expenses that you may have had because of your child’s difficulties. Assessments will take place at ‘baseline’ to the trial, at the 6 month midpoint and the 11 month endpoint.
In this study we will not be doing any physical or medical investigations on your child, such as blood or urine tests or X-rays.
We will then prepare a written summary for you and, with your permission, send it to the health professionals looking after your child and to your GP. Some of the activities will be videoed to allow us to study them afterwards as part of the research. These videos will be kept safe and secure in our research centre along with all the other paperwork and will be destroyed after an agreed period at the end of the study.
We will also visit your child in their nursery or school to carry out some assessments there (once we have the agreement from your child’s nursery or school). This will include making a video recording of your child interacting with a key person in school, such as a learning support assistant (LSA) who works with your child.
Treatment allocation for delivery of the PACT-G intervention
Because we do not know whether this new therapy will help or not, the fairest and best way of testing this out is to have two groups, one receiving, and one not receiving, the therapy. A computer programme will be used to “randomly allocate” each family to one of the groups. This means that the group you are put into is decided completely by chance and does not depend on anything about you or your child. There will therefore be two groups, one which will continue to receive the same services (provided by your local health and educational services) and the other will be with usual services plus the new therapy. This will be provided to the parent and also a key person (such as the LSA) in nursery/school.